P .

z/32 fiPR 16 01 02:46PM 011SENT BY WRSHINGTON LEGF\L FNDN

2009

MASSACHUSETTS AVCf$lJc, WA.?HINGTON, Q. c, 20036 702 588s 030,~

N,w.

Re:

CitiXcm Lahelifig

PctiLion TO Exempt Imtcrnal. Rcquircmenks

mfonnabios

From FDA

Tk pctitioil

Washington yursuant

Legal

Foundation J 1C.30

(WLF) hw-eby 2;~ require

submits

this

to 21 C,F.R.

(-TIP Food and

~WUCJ Administratiw
action I blat

(FT)A) to take
it clear

agprt-rlj.ciate
informatioli

admin5atrative
lrovnd

Would make

that

on a

A,rX)

S'DA's attaqlt of

to segulatc is

a tonq~~ny's with First

webbrte

as

labeliny
and the free

it@ product

inrwnsistent of
LIIP.

bt-jl.1~ tkre W&X Act Amendment.

S~WHC~ protections

a z-ulc, available

policy,

or guidxxe

E;tatirlg

that webtiit.A,

information including

Llresented hy~e~lirllc~

or

on a cun?rrnrLy's Internet

FlPR 16

01

02:46PM

011SENT

BY WFB-IINGTON

LEGRL

FNDN

P. 3/32

Lo other defined

third

pnrty,sites,

iives al U.E.C,

not

constitute ,q 321(m).
The

"l;rbclingO
rule,

as
policy,

by 1.1~ FIX& Act, ahouid

or guidance

C~rt.i~cs,r, .srp~~c;lfy that

a

intormation

on, itc

Lx product,

access ihl I+ through, product ingreditilll..s,

~ompany's health

websiV.n concerning or other referred

claims,

sducnt.ic~,rlal to pi lli&ernet

j.rlforrriation
iTlform&ti:-~~ltl)

(hcrcinafter
rr:ay,

colle~:i:I.jv~l.y not ncccssarily,

but

co~lvI:.i t.ilte

advertising.

ove~-L.~~n-~~o:~nter
coometics, gro~e~l.y Iredc

(OTC) drugo,
falls Commission

unzestrit-:I14 the primary

medical
respons

devicco,
iIr i.lity

and
ot

within

l-he Federal
lcng-standir19

(FTC) ra.ther

than

the

FDA, under

kuxctlce

and syrcement: petit.;i-IIIvL

betwesari ~:Ite. two agencies.2 chat the IQA adopt infoumatioc the h ot food

Alternatively, rule f pc-'I 1cy, ccmanies .ceason, from

requests

or guidance
labeling

exempting requirements

Ilat:er,rrcL shoald

FDA, f{-jr. whatever to the

be unprcpclred

to extend

L-he proposed

exemption

cntorcemezlt
r:c~i~l-;l.itutes

actiuu

WI t.he basis until

that

Internet
L2la.t. the

information FDA has had

an

labeling,

such tima

f-3PR 16

01

02:47PM

0llSENT

BY WQSHINGTON

LEGQL

FNDN

opportunity

to concitic2: with

WLF's petition, broad-baeed

Lhiu .~WW~IP.

CC 1.1~~yromulgaced public input, thst

its

own rulrr? UL' 1x31icy, cpccitically

addresses

WLF

is

a non-profit U.U.,

public with
nf

interest.
eupportcre 1:s

law

and

policy

center WLIP the

baseci .irl ~Jashlngton,

devotes

nationwide.
t;o

a substantial of indivldua1p

~xxtion

resources

detending

rights

and buainessas

to be free

LLUII P.X~FZEZ~V~

and unconstit.lit.!nr'~~I supporters wish arc

c~owsrnment regulation. physicians, about

Among WLF'e patients drugs, nnrl who

consumers, information

i1t.111 IIIHC:~~ food products,

wlthbut

to receive devices

medical

CJVFL' ~-lit: Tnkwnet interference

undue asd rtiyulal:ory intcrcst

agmcies-

unconstitutioxlsl WLF IVJH reEtrictions free

in
d

by government institutional

"lurlg-standing

fri opposing on the

by the

FDA and otl-re?- y~~vt?r~u~~r~l:al authorities under the Firat with Amendment. the

flow
1993,

of information WLF fileri its

a Citizen

For exaq-11 * ,

Petition Rolj.cy Activities drugs

FDA requectinq

that

iT withdraw

Draft

Statemel;t;

011 ~rlrluslry-Sljpported ~kf; la&l

as violative

Bcient-if.i.r: pro;tlotion
u.t Llle

tit~h F.t.il.uzational of FDA ,spprovcd

regarding.

and medical FDA refuted

in

deviIe:c?*,

Fi ml-

A.mendment

When the

to do SO, WLP filed a landmark decision. 213 51

CAlawsuit WashinqCon

in federal 3eqal

couzt

axid pL,evti ilwl v, Friedman,

Foundation

13 F. Suyp.

F)PR 16

01

02:47PM

OllSENT

BY WRSHINr;TON

LEGRL

FNDN P .5/32

4 (D.D.C. 1998), aooeal filed First dismissed, amicus 202 F.3d curiae 331 (D-C. briefs Cir, 2000). courts free 517 U',S.

WEF has also promoting the

numerous

in the

Amendment protection
44 Xuucxmart,

of commercial v. Rhode Island,

speech.

see, e.q.,

Inc.

484 (1996)s In addition Studies Division to WLF's extensive has published to the litigation, articles WLF's LegaL and other See, e.s.,

numerous subject

publications Daniel Positi,ve

related

of this

petition.

A. Kracov
Uses

and David

5. Bloch,

FDA Rcqulation Legal

Mav Inhibit Legal

Of The Internet 1996) (copy

(Washington hereto); Challensas

Foundation J.

Backgrounder,

attached Chanqes,

Sandra

P. Dennis,

FDA And DTC Advertisinq: Scrutiny 1999) ;, (Washington Steven Legal

& Constitutional Legal Finds Note, State

Foundation Federal

Contemporary Acpeals (Washington C. MacLeod, The First Backgrounder, and Promotion Court Legal

J. Rosenbaum,

Food Labelincrl Legal Opinion

Law Unconstitutional Letter, 1996); William Violates Legal

Foundation

FDA Sucpression Amendment, 1995) ; Melinda Guidelines Foundation WLF's mission Would Legal and

Of Advertisinq (Washington L. Sidak,

To Consumers Legal Foundation

Prooosed Free

FDA Advertisinq Of Ideas Further on its

Inhibit

Exchanue 1992).

(Washington information website,

Legal about

Backgrounder, activities

can be found

www.wlf.org.

FSPR 16

01

02:47PM

OllSENT

BY WFlSHINGTON

LEGQL

FNDN

P . w32

I
5

C.

STA?XItE~

OF

GROUNDS rule or written posted labeling, addressed issued to the policy on a

Currently, that addresses

the the

FDA has no specific question of whether

information

company's neither, subject occasional produce

website or both. in 1996,

is

considered

to be advertising, group

Although and various

an FDA working agency officials the

have agency

statements any coherent

on the matter,' rule, policy,

has failed on the topic.

or guidance information

Traditionally, company's advertising,3

promotional website

and similar

posted

on a as

has been viewed falling

by industry the

and the ambit

public

and thus,

outside

of FDA labeling

FDA's Director of the Promotion and For example, Byron Tart, Advertising Staff of FDA's Center for Devices and Radiological "We are leaning toward the fact that Health (CDRH), has stated, if you have information on your home page, we see that probably Device Information on the more as labeling than advertising." Internet Like1 y Constitutes ,, Labelinq, M-D-D-I Rep. (The Gray Sheet) July 15, 1994, at I W 5-6; see also Marilyn A. Moberg, et However, Melissa al., 53 Food Drug L.J. 213, 217 (1998). Entcavage of FDA's Division of Marketing Advertising and "We're letting drug companies Communications (DDMAC) stated, choose whatever category of current regulations they think best fits their presence on the Internet." Druq Ad8 Castins Wider Net, Findinq &,,,.Home on the Web, Am. Med. News, Nov. 20, 1995, at 3. Another official with DDMAC, Louis Morris, was quoted as follows: "When you see an advertisement [in a magazine], it looks like an When you click on the Internet, you don't know." advertisement. Medical Ads on Internet; But Baltimore Sun, FDA Wants To Requlate Rules on Promotion for Druqs, Devices F,.eared To Block Free Flow 20, 1996) . of Data, at A4 (Oct.. the Animal Health Industry considers Internet For example, See AH1 Weiqhs in an,FDA Requlation of promotion advertising. Internet Promotion, Food Chemical News, December 23, 1996, Vol.
38,

No.

44

ISSN:

0015-4337.

FlPR 16

01

BZ:48PM

OllSENT

BY WftSHINGTON

LEGFlL FNDN

P .7/32

regulations, State

but

within

the

jurisdiction advertising.

of the

FTC and relevant

authorities Despite the

to regulate lack

of any clear Letter of the

and uniform was sent

policy

or guidance 19, 2001, by

on the

subject,

a Warning District on the perfectly just

on January

the New England

Inc.,

FDA to Ocean Spray that

Cranberries, to seize and found on the

and posted company's

FDA's'website,

threatened cranberry

that

good and wholesome because certain links

grapefruit company's to all

juices website

information allegedly failed

and related

to conform This

of the

detailed

FDA labeling that

requirements.4 at least

enforcement district labeling

action office under

suggests Internet

the New England as constituting

views the Act.

information

In the
--

Warning

Letter

FDA claimed

that

the

company's

See FDA Warning Letter NEW-DB-OlW from Gail T. Costello, New England Office, Food and Drug District Director, to Robert Hawthorne, President, Ocean Spray Administration, atr. http://www.fda.gov/ Cranberries (Jan. 19, 2OOL), available A copy of the Warning Letter is foi/warning~lettors/m5075n,pdf. attached to this petition. This unwarranted and eurprising enforcement action, issued on tile last day of Clinton Administration, is reminiscent of an The abusive enforcement action taken by the FDA in early 1991. of then-head of the FDA, Dr. David Kessler, ordered the seizure 12,000 gallons of perfectly good Citrus Hill Fresh Choice orange juice made by Procter & Gamble because the word rffresh" appeared the juice wan made from concentrate, a fact noted on the product; WI-IF but in print smaller than the FDA preferred. on the carton, believes these kind of enforcement actions are not in the public interest and are a waste of FDA resources that could be better from truly unsafe foods, and directed at protecting the public drugs and devices. speeding up the approval of new, life-saving

4.

._-_ ,--

WR

16

01

02:48Prq

QIISENT

~W-IINGJDN

LEG~~L FNDN P. EM2

products
4c!< (.L,) (;.I

rli.scuasa(l.
(D) of

on the

s..ib:cs to be mishrantM
21 U.S,C. 34~((r.)

uncier

cecelor~ subject

the AI:~,

(1) (II), to certaiil

and thus

to seizure. haC3lth r:laims,l'

sl.'wr-:ifically, 1ncludlny

L'ISA objected Lhe following:

"unauthorized

Beta-carotene. , ia a powerr711 antioxidant . . , asw.)ciated 'with's redluued risk of Born.? cancers. Both the &~rgoo~~ GHlxral'p Report wnii the National, Research c~ouncil.~s Report cancluckd that eating pl.enty ~2 foods iligh in beta-carolem may protecL against epithelittl cancers ; + t * ~r~r~berric~ may also prevent certain ktrmful in the rncmtlt from aticking tn l.he tecthi bacteria

Cranbcrq juiw coLi h;lc:Lcria, from adhering

inhibiter3 the cod&nil sign? ficantly which cal.r.c;e 00 to $0 ~PY-CMIC af UTls, tn 1.l~ urinary trac:l:. did
noL indicate

73.

Remar:k&ly, ctriy of

the

2';3.4 War.rr~ug Letter claim3

that

jt, found the

Lhesa hetr'lkh

to be ,Calsa or misleadjny;

rather,

5 l'he FDA has authority i:o dean toad rn be misbranded iT "its 21 U.S.C. 15 l&e].inq is false UL- misleading lr,! any particular.'~ the FDA never ctated irl ite letter tn Ocean 313 (a). Tellingly, Spray that afly of the hcslth claims were lqfalse LII mislc2dinge under th'i,ti provision; curl&equently, thof;e. statements are i)r'"tectcd by the First Amendment IJndkr the commerc:ial speech The only referewe in the WarrJirlg Letter abelIt. arly doctrizlc, jnhrmation on the websitc b@sirq "Lr11se 01 miPlear!i.ng" comcp. at of the follf.~Wi.ng strainecl argument: certain the concll.lF;i.UL?. StaLwnen':s an the w&tiite, ouch as 11~~ the icsrie af cllitibiatic resietance bcr.:ljlnes more of a pwblem, drinkirq Ocean Spray m~df4j;lll'e for clranh@r,ry juice c0ekta.i 'I every day may IJ~ a valuable (contmu~d...)

----

W?

16

01

02:49PM

0lisENT

BY LGSHINGTON

LEGQL

FNDN

e
I;P addItir.lrl, the FDA fr~~rld that certtiin cthcr heal.t.ti claims

FlPR 16

El1

02:49PM

OllSENT

BY WRSHINGTON

LEGFlL FNDN P.

lW32

WLF believes

that

LIIEerncl

information,

partiiculariy

Lfuse

Iis;;eful

function.

my

tnaki

ny illlpor';aat

information

avclil.able

to

food

pr.xxkxts iE

that:
clearly

they

believe

kn.cfit

them.
intoresr

In short,
and sh~.~ld

mdl
be

information

iI-1 the public

encouraged. By trcgting certain

TnLernet

infotistiofi

as hicjllly

reguPstcd

beyond
Act 1

nrlyLhing
Morcovoi ,

contemplated as will

by C~~~iy?:ess whell it later in

adopted

t.he PD&C

I+ discuascd

fl.krrhnr

detail,

fc~twh~ental speech. See

First
Yca.rst~u

A~end!Wnt
v.

ylotectiona

of commercial 65lJ (D.C.

free Cir, 199YJ

Shalas,

145 F.3d

ticienrific r,ot protected

rlgreement'l
by

a.rt! inherently Plrc~t Amendment. .

mislesding, wa flatly result

arlil therefore rejected of by LTIk

the

cr1l.rI t: a.3 rralmogt treating Internet.

ttivOlmwtf)
idormation

Tl~c. likely QP labeling

Lhr: FDA,

wwrl.d be the

contrary

to the p&l

ir: intereat.

IndeeB,

thatl

is

the

apparent

FlPR 16

01

E12:49PM

QllSENT

BY WFlSHINGTON

LEGAL

FNDN P. 11a2

10

rccult remove

in

the Dcenr~ Spray

case whcrc its

the

conkpany ~a.3 fnrc:& No doi.ht, wrath of other the

rr~wdznns

to

1.11~informetion wiching

from to avoid

websire.

companies, will

t.hE-t enforcement their First

FDA,
on

be fah.~~arrlI:

LO exercise

AmendmenL be deprived tihich

Lhc Ir-rternet. vaiuclble entitled

1.

AZ 9 result,

consLLIIIvr% will information First

ol; RR

nutritional err 7-eccive

61~1 health under the

they

Ar@ndment..
As L&e:ling

FDA'B Regulation or the Internet Inconpiatent the E'D&C Adk..

1s

devicea, produced red

fail

and cosmetics under iL;nr-ritary

WF,~:* not conditions, the

injurious

to health,

were labeled. and labelln9 A

and were properly its labeL $ 343. in pertinent

is
to

mfsbrandcd
meet cert.ai.rl

under

FniX Ar:L if 21 u.s;.c. "label" inns,

tilxtndards, the term

ITr~tl& the Act, &splay contairlar "1 aheling or qraphic or wrqJpe!rs,

321 (m) .

part,

"a

ol: wxiclten,

printed,

ox graphic 21 u.s,c.
lahalb:

matter

upon the

jmmediate

of arry A?-ticle, " i3 defined {l.) as -all

pi 321(W) _ and other

The term printed,

written,
.i

marter

up011 any article

or any oL

I:F; conteiner:,

Or (2) accompanying

sur.:h nrticle."

21 u,s.c. AIJd

The B'jXi,'s TQ~~I.I,~ dt.~-Jly definition i.s assenkially p 1.3. identkical

o-+ "lab@l"

"labeiirg"

70 ~IIc? atatutosy

dctinitioc.

&gfg 21 C.P.2.

~IPR 16

01

02:49PM

011SENT

BY WQSHINGTON LEGFIL FNDN

P. 12,32

T'he i.tisue as to whether "labellr~~~~ dcpcnds, in part,

lnternet

infrxrrl.+I-.i.on it

constitutcc said that

the

CIJ+I~Iwhether

can be

the

phrase

"accompanying

k4txh article"

i3 no2 restrictert
CI L.. t-mnear

II'I the article

printed
LIL

ma\-.i.ei that
The court

is physically
detexmird

ateached
khat

package _

brochurca
(that

Cent by the r)l: d

WEFG

maker of certain
mixCur+.

k~11:h

food products

consisted a~ld which

of vitamina,

minerais,

SIB herbs),

the

pr.i~'ked

matter tense
However,

to

"accompanyt'

the pr.xxIuczt uontempaxancously I1labelingJ"

i.llnt

in a phygical
materials.

in arrl~ the

LO be considcrcd in ~ordel

ke-/ point

further

bc assumed that t.he ' For pu,rpoBcG oE this pezil i<')fl, it will intormatian pr~i-eii on a webpitc ic Ilprinted, w,r.:t.ten, or graphic HowEver, St shoul r.3 rrinllter" tinder the definition nf T~l&eling." bc noted that a~rr'tit-, recording3 can also Be plc:t?d 012 d COTRpanyC in.Cr.)r maticn so tranemitted canno;-., wel..Isi'LeI and to that extent, OY t~iabeling." Nor could the bv detlnition, cnnSLiI:ute h "label" audia recudings ox 0r:o.L FIG ~:r~usidtr aa II1abeIinr,lll comnurications made I CJ a perapr. who may call a Cnmpuy's tallFurthermore, 'chs FDA may frep rrut&~c~; fez- pradnct informatiorr. labeling exemption petitiullrr~y;e)rs decide that the IIIIYRT~~C~L drrectly shouZ.$ noi. npply to compsnies that se11 i:!ltrir producks to the conajcmer from their wnhsites,

FlPR 16

01

02:50PM

01lSENT

BY WFlSHINGTON

LEGFlL FNDN P. 13132

~r'oparly

undcrctood, Lli'Jgition nbout its

the

Kordel

decision

dn*!s got posted

on

suppovt
8

Lhe FDA'3 a_oparent company's wtibxite

that

informRt.!.u;l constitutes there

producL

labeling. or

In the

cdsc of Occirn Spray, al],cqation that. Lk

fnr, example, information frui.1.

was IIO evidence

on l.1~ webaite juices.

"was 1.1ser3ill does not

nor

the cell

Sale17 r)T tk-.e comp3ny's its juices on-line

uw~ally

Ocean Spray from iLs the websito,

WI the
iuc

concumer ix

do

coneumers

laptops

dcce~s

Incernel.

while

uesp-ll-.p

Llle

FDA's penchant

T'or- paternalism,,conHume~~

arc

quite

pther

c OIIWKS!I ooda , f Purthermore,

The

information to the

OZ ~hti wabsite
1 abel"

clearly

WAR r:~t a@

ar: "essential

a-gpplamcnt

attache&

to Lflc product

FlPR 16

01

02:5BPM

DllSENT

BY WFlSHINGTON

LEGFlL FNDN

13

wab the
informal~

csce
i.r-tl~

in Kordel.' "intarxkpendent."

Nr~r- was the prvduct The Court far 1~s~. in

noted

and Internet
chat. the and oaLe of

litcraturc
the drug.~~
that

l'wae designed
rn.
Ocean

Lhtr? distribution appear, nor did for

711: 350.
SprayC

1t does not website of iLti

in

the

FW+

cl riil[l,

"was d~,rigned
Juices.

use in the the iilformation

distribution interstate and the distrLbut

lahe.? i.ily .

and salen
L.rhnsaCtiion

fmit

V&wing the Internet.

it3

catirety,
not.

fruit
Fan

juices
;Prrlg.C.dlu't

are simply which

pelrt the

of an "integrated Lnternet
in.Cu!rl;lt.inn

renders

The purposes decexmininij the court

oP a statul.t!

AI-C also

instructive
As nnt4

in in ,&.3rd~,Z,

l.11~:meailing concidered the

of statutory "high p~xyosc

terms.

of the Act

to protect

--

..

.-

that the ' The FDA Warning Letter to Ocea11 ii~ray began by noting company w&site WAS yrinted on the container labels, ~IIlyyrsting I..~'IH~. the FDA may deem all the inrormat:iull found on thooc websites Rllt. Lha mexe as comebow incorpx.+I.i?;trl by refereacc in the label. far:\. L~ML the websitc address. is priIlt.4 ton the product label docc not make the Int.er:rlt!L hfqfrnation kound on that adr_i.rati~ an "esserli. i;lrl supplement to the label," any rrrcire than the printing or free number on the B name and d1:313l-e56 toll of the company' label of a prc&.c'c subjects company literature I..rx FDA Labeling simply because those olaterials were made available raquiremenro If the or wrote tb the rmmpd~ly. to persons wh ~/isited, called, exdorcement power oTTeT factor that triggore B'UA' s excrr.: i se of its websitc Internet label i,rlcj is simply the? prcoence of the (.:I~pany's requests that the FDA al address on tlnc product la\bel, pet:iL.iuller Compe;niea -fndu.rLry'. least make Chals. jrc-Jlicy clear to the regulated wl~u wish to avoid the' lnternet la'i~~.li.ng problem can then choose to do so bv Tr2mcWng Llleir website addrcsc from their ,j>r-l>rluCt addrccc in labe?l s, a&i decide whether to promote t.heiL w&site other ways.

QPR 16

01

02:50PM

011SENT

BY WfXHINGTON

LEGQL

FNDN P. 15132

14

protecr
aAc%%l) .

themselves Those not

in this

field,..." of over
i

Id.

at

349 {cn$xasis
aqo

"conditions" present trxI*Y

H Ylalf-century

are age. Intern& 'up. the

ccrtairAy

11 this rationale

consislmer informarlan
Par rc;l.gulaLing

MOE63iKlF"rZaKll..l y', the Kczdcl food-product The r@asoc for Infv?ieL website, World wrify website.
and has

intormation t.h:in is
read

ag 1akliny that:
the

simply

60~5 nor hold

the

concumer

who has 3c.jgyed onto

infarmatiu~r

LlOsted on the Compaays finqertips to search Lhc

has the

ablLlty

a~. his and cacily

or her with

Wide Welt quickly or aupplerrieat 'i'his

a cli c:k of the posted on the

mou~c to

the

irifn~rr~~io~l

company's ks 2acltinq of
fur

in:st.al~?; access
store

to unlkmited the

1nfrxxldkiun

in t:nP r.e~~cljl information the

actting
a

where and its

~':onsumex'B source is label

llmit:&,

about

pro&.:i.. contcntc

ingredients

most I+KI,,

tt.n the

of the prodil~l.

and any

*km:conlpanying printed To be sure, lower

materlaY s." court casts decided aftf2.t KrJxa suggcct a

F~~rthe~ evidence that C'mqwsn would not contzider "labeli,rry" to include informaL. i(-Jn posted on a company's wehxile ib found by fn 27. For example, ot.h~+~ references to 'llabeltngfl irl 1.11~: Act, ent.it.14 "Prominencc7 of idfoxrantican on 14bel,1' S U.6.C. 343(f), food i * "x-tisbrm~dcd" it Ifany ward, .yLcleement, or other information required 11y or under autrhoftity of t.hia Act to appear on the L&e1 ~~,Jabclinq is not prx~loi.nenCly placed thereon w1t.h such conoplcuousne8s~. . . a& ip such terms as ti1 rw~der it

likely t-c> ?.:c+read and understood hy t.Irti ordingry individual under: (ernphas,iw added;. ~:usto+ry conditions of y11rI-:hase and mu3c_.r' s. A customary r:c)r&tion OE purchaeing ar,d'u~i~.~g fruit juice or ~sl-.her food products does nnt. erkail accessing and retrievirlg frunl I.he company'g website, from which one cS'11 infer intormation such inLormation 3% t.h~I. Congress did not inteEd tu rqulate
llabelir~g . I

FlPR 16

01

02:50PM

0llSENT

BY WQSHINGTON

LEGQL

FNDN

P. 16/32

15
broad

reading 3. Peld,
,

of

LYE-!t.erm uaccompanyinq.11

Eke Sarah

E..

Tny1r.x

&

Harold
the

Promoting
54 Food Drug

FuncLiunti7
L.J, 423,

Fnods

and Nutraceuticals

on

rnt~?7lrl

444-46 that

(1999). the

Pnwever, for

closer

reading

of thoee

WHVS indicate

key factor

discernible labalicg] there

Lk

~CIUB between ML i:er. 11 &$.

at

product

salw

and the

[putative i
thar

ll.6,

Petitioner

subuliLs

hecause sales"
dlld

is no "readilv * disL:t?-r-rlLble nexus

Tnrern@I

between

product

information, I")
Adve:rti ~lng,

such information on the other of

AC.WSnot hand, lacks

constitute "immedj.l.*

"labeling, connection .&~kLles the

with Sl.wrlirrrl

the

sale

the ymr311rt.~~

United

StateE
1964).

v,
Rw7a.use

Vineqar,

33B F,Zd
,~II

157 (3d Cir, an

Intcrnct

iafolmation with the talc

qtI.Lestiion lacks

"immcdkote

c:onnecClon such
i.nfouwLiwl

of the product.,"
by treatsd

lir.liLioner

submits rather

that

shrwZd

PO advertising

t:l-la~"~

not permitted to stretch the mean.i..rq of the term As t.11~: kynnd that which Corqrecc had intended. rx12,c clear, agencies IIIA~ mt enlarge their jurisdi~;t.ir.wi IJVFL' wtivbties chat Congress did not i&aaJ. LCI regul.ate, rcgardlesa oE the ayexy's c3xpertlse and belier that of the statute better serves the pub1 :I-: its illLer.,pI:~r.?J?.loz! intcrec-,. &cc FDA, v. I&Q&L & WA11 !AI~IWUR Tobacco Co., sz9 u.E. 120 (zonn) Furthermore, where, w here, the Ljrvad interpretation of a statute rait3es serifx~s constitutional intesprct the statute narl:iJu~sy Lu avoid quesLiCJ~ls, Khe C'ourt will seackng the constit.nt.fwrd issue. Solid Waetc Aqe3cy of.. Nfxthern Cook County v. U. 2. Army Coras uf msi neers, 53~. u , s ,
153 (2301) _

T1?e FDA is "accompanyiliy" Stipreme Court

APR 16

01

02:SlPM

011SENT

BY WQSHINGTON

LEGQL

FNDN

P. 17,32

16

labeling. As a practical extremely included company, costly not but only matter, to police information it would be virtually website if impossible "labelingll provided websites accessible requirements? pre-approval that by the maintained through Would and/or they a and

a company's about

the product information

hyperlinks

to health the to

by third-parties. company's companies premarket propose wabsite be forced notification to place

Would all be subject to submit all

information lllabelingll FDA for

to the

the

so-called

"labelingI

on their these the

website?l' practical. FDA could the -and legal legally issues,

petitioner

In light submits information -t- which adopt noted, that

of all even if consistent

regulate and the First

Internet Amendment

with it cannot

FD&C Act the

we believe

FDA should

nevertheless policy. As under acts as well is 55(a) (1) of or as its '

WLF's proposal the

as a matter advertising authority

of sound public for food

FTC regulates statutory under

products

independent practices
12

to prohibit 15 U.S.C.

deceptive
45,

S 5 of the prohibit

FTC Act, false

and 15 which

"any

advertising" 15 U.S.C.

that I 52,

*misleading

in a material

respect." standard

The FTC uses a flexible

of prior

substantiation

For an excellent discussion legal iesues involving product Taylor & Feld, ~~.upra.

of the various technological promotion on the Internet,

and see

16

81

02:51PM

O1lSENT

BY WSHINGTON

LEGRL

FNDN

17 claimo
Fi.m2:

in regulating Amendm@nr than

sdve,rt.islng

that

is more conoiatent requirements

with ror

the

FDA's bu~de~Eoma labeling

MOYQ pertinently,

the

FTC, fcslluwing

the

enactment

o;t the

speoltic
?ol

quidanze

on feud

ar3vertising.

&g

FTC, ,&fo,rcement The F"L'L:

ic:v' Statement, false, food

on Pood Advertisinzr Im~~)~iI~tlcling, deceptive product advertising.': Internet

(Mar 1944).
and/or

prohibits n?.aims in batte:r conctitutc

unsubstantiaLet2 the that. in thic b"l'~ ip i>ltiy ;LTCQ." enforcement tha.11

In

Trt addition, information lead

SuuiLed fnr

regulating
k.1dwi.q

advertising, duplication star,daxd.~,

be

t.aken the

511111, avnid 1.0 and rcqulatory

r.he

oi offurt WLF stirnits

and conflicLiny tha",

the FTC, rather Internet

FDA, should

the primary

agency

t.n regulate

FlPR 16

01

02:52PM

011SENT

BY WQSHINGTON

LEGFlL FNDN

P * 19cl2

of food merely

and o:her
acting

products

via its

the company'@ w&site, statutory authority,

FDA 1s not but to YicJh?s the ao also is

in -a>cc~ss of First

v ~~-11a~t.~~?g the
dicsemicate

Amendment rights
irdwmation, sllch and

of manufacturers the First

truthrul to receive

Amendmrnt

of consumers constitutional "label.ins" is

in rcxxnakiuu.13

Accordingly, Intcrnct content adopt this

implications further reason

of

requlatinq

why the

FUA should

The qovernment ncirher showing false that;

nor

may regulate
relnkd

commercial

speech
acLiv,ity

that
only

IS
upon a

t.r) RT: ~~rdawful

(1) the

government

hila a "subctcntial"

interest

557,

5GG

(1900)+

FDA's

treatment

oL Jntcrnet

advertising

Amer?dment implications

of

its

conduct,

or simply

is

Inditfsrent

LhL the First Amendment as The sL?.pretne L:O~JF~has made c:lrar, protects both the right0 of purveyors oi information to speak and a Viruinia iIl~0.C llld I.,. i C JII . 'the right of their audience to receive Sl.aLe Ed, c;;if~v v. VirUinia,,,,,~,,~,tize~s Con,sumcr Council , Inc., 425 u.S 748, '756 (IY'/b).
e

FlPR 16

01

02:52PM

011SENT

BY WFlSHINGTON

LEGRL

FNDN

P. 2042

19
to them.

Pt:t.iI'.ione.:r

suhmlb

that

the FDA's

requlation

af

the

First, challenge claims

l?DA's Warning the

T,el 1..kx Ire

Ocean Spray

doe= not

cvcn tlrld health

truthjklncsa

of most of the stat.enle'lI..n

many of

ma& OII t.hw website!, acid . . , is

whxch are commonhowledge,

women

such 23 "ralic i I_ helps challenging the Internet prevent the

i.n'lpwLar~t. ,fnr pregnant defects." I..,k display it does not

Xat;har,

because

certain leyaljty

birth of

FDA LB information
of i.llr

of csrc,ain meet
all

on

simply

bccsuac

Fl3A's

More importantly, r~etsmis wcbaite, to the far for regulating

even if the

Lhxr-?

WATP v~.1.id public ok the company's

health ~1 iiu

cantcnt

epeeck

I'DA' s &ttcmpt. game extent

i-.(-1rvt~jultlte

the information labels affixed ita

That

as. "labeling" to is ~IKII.ILICL is purposee. "rhe

remedy

FDA regulates
than

etxkPn.sJ.ve NICLCF

necessary hclu

to achieve
rw:cqniwd

In in

ouch cases, L.kLe first

preferaS2.y

the instance
a

Supreme Court is

nor necessarily
rlT disclaimers

a prohibition,
or explanations,"

but see In evt3> if and be

requi~wiiwil.

Ye H.M.J.,
Intcrnel;

455 -J.S.
irdorm~L.:i

191,

203 (1.982).

Zhx example, construed

CXI rin1~l.d he legally

ae ifLabelinqll clnlrfd

zhue Eub]cct
sat,isfiwl

to FDA -jurisdiction, the First

t$e FDA's

ilkerests

(:r.)r~HisLCerlt with

nmendmenc by postinq

.-..__ ,_
P. a,32 FlPR 16 81 02:5ZPM 81lSENT BY WRSHIN~TON LEGAL FNDN

eff~:L claim the links full

L%hcJ

that being

the

FDA has ILO? approved or that

uiy

the

worrlir19

of

rtlne

health

[Iiscussed, of the praRllr:t

those

health

claim,

found

on

label
tu
1ar-qdaqe

have been apprvvetl

and FDA

by WA. thaL

Posting provide labela the may

t:he

FLIA's wcbaite

regulations

of ctpproVed health
Option.

claims

.Cor container

~~~5

allO:her

The SI:~~rwne mwtitutiondly

CWTlple,

Court

hils reycaLw37y to outright

Bar

Eound

diaclaimrrti For 350 tlS+'/./),

prcfrrable v. Stclte

Yuppression. 433 U.S.

i.ri Rates
so-ted

rr.C Arizona,

the

court

Ll!.irlt. . , at least cln j.J'lIC,lrmed of information

aqument

i,t Seems peculiar to deny the cmmumer, YoIrw! of the information il~aded to rcaeh decis;cjrr. The altcrnativc--LIm grohibitFon Jdvcrtisirly-serves only to res,tr:ic:L the that tlows to r:orlsumers , Morecwer , Lk tissumes that the puLli c Is not sophisticat.+cl rad.lizc the iinitstiohe (-Jr advertleinq, kept in ~gnw~an~e thah public i.q better correct buL incompl&e infcrmatiar.i,
433 TJ.S.

enough to anti tllclL- ttne trusted with the information

;it

374-.75."

Ir~l~ed,

precisely

becallsr

--,

-,
NZtorrley Reqiatuicln EIXA~ IJiscdplinarv &~nlrr~ 91, 110 (19YU) (the states iriterest in cu~~s~~~mers from being misl+ar_i by l~~wycra' 1etteslitia.d
\J.

I wdS*, Qf Tll.inois,

Fe?1 496

U.S.

prcvcnting was InsuffIcient to 6atlw.Cy the state's t-,eavy burden of justifying i9 categoricaL ban agairlxt the dissemination of dr:curato factual infor.lllat-.ion to the public. Tea L-he extent that D.dch state;wnt.a could confuse CO~IRII~W~S, the Oourt sugyes~etl a tlissclairnOr about tche sl.drdards of ettorneys' specialtie or concerning I-he cerCifyInq oryaCzatio.ns. see al,m, Jn RF?R..M.J., 455 U.S. 131, 206 (1982) (the state "may not. ~.)lace an aboolute ,prOhibii.i nn on certain types of porentially misleadirly information. . . iC the information nlay ijl~n ha presentad in a
way tlw,i is not deceptive) .

QPR 16

01

02:52PM

011SENT

BY WFlSHINGTON

LEGQL

FNDN

P. 2242

affixed

to the yr'udtx:k

OT on printed the

matter
~KI~UCL,

that
b11r.

is rather

intended so-called

to

and does physically "Interr~r!l. interect

Tnl-.em.eC, prcvdously S~WJ

accompany

l.dbcling, in protecting as well

If the government that ~:lrl~*

d

haa J-~Jw of an yaternaliulic: individuals that class is of that who PCCCG~ the infl',rmdLion. the computerAS

as in regulating
khe
laqs

discussed,
oonEtlmcr

reason the

for

this

who !>ostad

onto

Intar'iit:L
wcboitc

nnd reads
is likely supplement

the
to be that r.rf

informal:'ioII sophioticated informarion mouse. Recent la&l

on the

company'c

er?ough to hc hl11r I.LI verify by searching the Worid

or

Wide Web with

a c-:7i(:k

,the

litigation
claims,

against

the

FDA fol

LW.JI~~~~~.+PCJ certain activities of

a

-i7-y , lJ?alth

and promotional r.i~e r.xmtsnt by the

suggests

tllaL

thE: FDA'0 attempt as "1 aheli.ngtf infirm.

to regulate be viewed

comp~~y~s

wabcitc

would

courts

BS constitut-.inirrllly

'l'he P'UA'C hootiliky the

2d

to the Legal

First

A~en&kwL

was

ai3rlre~;sed

by

r:n'~rrl. irk Washington 51 (D.D ,C. 1330) , 4 l-s pol.Icy

.b'oundati.on Twqxl

v.

Frie&pan,

13 F. Sups, the to off-label yoeik

i.cxi

In minqto.l? of prevsntinq likUdLUL.FI and dcviccs.

Foundatign,

F'LM was

sued over phyoiciana

the dicocmination r?es?rj.hing The FDA took "1abelj.ng" bocouoc the the it

of third-gazty druga

use

CI~ FDA-approved that the 1i

t.p,r

~1 ~11.econstituted

alleqedly

FlPR 16

01

02:53PM

011SENT

BY WGSHINGTON

LEG17L FNDN

P .23/32

accompardedtl

tzhe drug lil~rature the district.

ox dev.1~.

Assuming
withirl

arqucndo
khe purview

that
ot

the
the

off-label.
bJ.xcC Act,

WILE vlabaling c':c-ll.irt noted ;

;n asserting that any and all .rl.*ientiflc claimc about the safety, eCLecrivanesa, side contraindicatiwk8, effects, prescriptson drugs are gnd the like layarding ~X-E:~UIQJI. ~i7ej.y untruthiul or misleading 11111..i.l the FDA has had the 0pgortuni.t.y l..u evaluate them, PDA exayy+rra.Les its overall place in the uiv~rse.
13

F. SU&I~I. 2d at policy

6'/ .

The Court I:he First

went LX? 1.1.1 find Amendment's

qeech.

that

k'~A'm offc'rr the

label

violatad of truthful

protection

diHYemination

commaxcinl

In ,Pea~fior~ 'v. Shalala, Court was taccd with

164 F.3d
to

GSO !D.C. the

(lir.

19991,

the

a challci!~[jf:
mandate

b'lJA'c attempt

to

circunrveul.

~IT~XSS'S

when it Act

ankot.rc.3 fzhe FOOT and Drug

111 FlTAMA,

Rdminiskratioa
Cvqress claims authorlzcd base0 :.\II

Moderxl.j.zation food
"autho?itativc

of 3997 (FDAMA).

manufacLurErs

to make dieeacc 01 q~~irlified otricter

or health federal standard UT

statements"
t.hrlr~

scientific requrir irty

bodice, "Significant

rather

Lhe previous agreemctil:" the

scientific .inr:~rporated into

~bnuc tlhe claimo.

Sc:ient:'i
Usinq

'rho FDA neverthelcsti acJreement" hybrid standard

,, "Eiqnificant

t.ic

the new FDAMA standard. three of faux

this for

standarr?,

i:be FDA rejected

1xeeiLLh claims

On apgcdl , the not meet .FDAB vague

FL& argued "siy~.i.fic:ant

that

any health scientific co~lcl

cI.ai~w

Lhat

does

aqrccment" he ha.nned

stanrla-r-t3

waw .:rlI~r.entl\j

misleading,

and tliua

ouzrlqhtl

RPR 16

'@l

E32:53PM

OllSENT

BY WhSHINGTON

LE&L

FNDN

P.24/32

23

41

I i?r,na:.ively, the

even if

the

claima required

arc only

potentially
al

mialcadinq, the

FDA was not

to consi.der of warninqe. liiaherently

t.er.ualivbb: The court

to of

b;ln fillnh i-is c~~u.i.ri.nLj disclaimers quickly dispatched the WA's

appeals argumbnt

misleadirirj"

2.23fol.ir;lws:

As WC understand tt;e government, itc firEt argument runs along the following linea: that heal.~11 r~:l~.i'ms 13c:k,i,rly UyiyrlificaL7& scientific agreement" arc i.nhererltI'y misleading because they have mch an awwwme irnpacl 1.111 c'!r'r'f'Isllnlers as to make it virtually impoocible for than to csrcrcice any judgment at the point of ~tiI.e, I? wou7.d he AS j f i.1~ cuLxumtl;s were asked to buy something while hypnotized, and therefore they are bound Co be misled. We L.11nk r1ii.s contention i is almost frivolous,
164 F.?d P:. 655.

(emphasis
Zaund 'rmlt3.

in origi;?al!. b'lJA's llinherently

evcn

Eignificantly, mislear3ing" health "at

the

court

of eppadc

that
waker

argUm6?nt r!I?A nnt.

if

the

proposed

claim the p"-'iJ!L

were on the prodyJct of sale." A fortlorf,

label. the

and read by the FDA's aquutent: on the

Consumer
is

even less which

anal

compelling ie not
~hr!

he..r~ wi1.11 rt+tipect prcacntcd consumer making to the

has

to information consumer

Intcrnct of sale, the

at the point

whertl

p1clr1l.y

UK Lill\e to evaluate

information

bafore

any purchase. FUA's alt?;mativy claim the lfpotentially FDA appmwd the nrgiln~nt. that consumers because
tkc

ne for. the
r i rod txhc
healtk

might

micleading" t.he cldim,

const~mers of appeals or

might ws
~1

think SO @ck

that

court

to reject not
bc

FDA's arqumcnt remedy for

that thiu

disclaimers
allowed

warnings

would

a cufficient

QPR 16

01

02:53PM

OFFSENT

BY WSHINGTON

LEGRL

FiWN

P. 2542

24 prob1cm. approach Tn particular, failed the court held t.hilL the FDA'8 regulatory of t.lw Central
possible

to tc~~l:isfy c0nclucG.n~ that

th e finai tlit:

two prongs

H!Jtl,Son test, diwlaimers rzll.lng, all-too-fm the

PDR must consider barls. to ignore t.irr.:Lics

as ~llernativas FDA to this i?iar

to outriqbt day corlI..irm@8 delaying

Despite it

this

clear irl

by enyayiny when faced with

administrative

&fcc,3;

Omeua-3 PaLtv

3Sclda and Heart Di.uetise

Dieewe: (March
t-jf

Fulnt.P,

Vframiq

a,.. 'Vitamin

B-,,, and Vascular recent cace,

Ld, 2001).
FIXON Was

1~ ilrx-cher on Firat p\~a~nacy advertising States

13

r3 provision that sought

struck

down

Amendmel'lL y.rnllnds (one that or

1

to prohibit for special

a r:olrtl,".'itrldin~ caooa)
from

combines wrwting v. the

various that

drllg8 it

drugs

hed compoun&d. Cir.

Western 2001).
co

M~di,cal,,Ccr&er
Yiates,

3hal ADA,

238 F.38. IUYU (9th fmn71l that it failed

jQz.L~r73

court

of appeals that

mAMa wac to aatiF;Py

riddled

with

axccpl;iuris and tourth

t.0 rhe rule prongs of

[he Ihe

Sirt.!Llrld, third, ban did preventin

assert&

Lhe ?F?ntral

HUdSdn tect.
.i,n

not

se:r'v~ a substantial widec;prcild ccmpounding,

a ltmatxrial
Lhdrl

govcrnmestal r3i.d not dcgscel'

Speculation,

i.ateratjL "Directly

advance"

the

irll.cr6?st

to

as demrsnsI.r,+~~wl hy and waD not to 2.1~ speech narrowly

empirical
tailor4

evidence
kcause

ratker

"worlcable exist." a.

altarnatives at 1UN-96.

rectrictior4

RPR 16

01

02:53PM

011SENT

BY WfGiINGTON

LEGAL

FNDN

P. 26132

25 In sum, even if the FDA could rcgulotc Internet information to apply health o;t the in in a the
claims

under same
a

,I:he Act. AS nnn~rit.l.~r.J.ng labelinq

It

lllahellng,

'1 any attempt websitc

run

requirements

to a company's nauld

fox sfoui

do&e to labele

on the product

First

Amendment _ pratecrinq
mt.e~.i al

Tn p+.r.l:i I-:,IJ~ IV, .-911y ti y.~ve!r~~~~erlLal interest the concumcr hoc not
been

shown to be advanced content

dRgree1

by regulating and there

InCerne?

a6 "labeling1 to any of

instead perceived
rli scl

of advertising, concern
_"

are alternatives poeting

by the

b'U.k, euch ac the

A i mw-si

Accordinqly,
Tntw-net irfnrmatjan.

thcoc
as

casts

suggest,
in

the

PDJJ's treatment as

of

~laheling

the

same category
Amerdment,

traditional

labeling

runs

afoul

of the Firbt

D. &lvircmnlr.rlt~I Petitioner
oF an wnvirnnmAnr.a? clsimo

aRF.ewpm.e!nt. cxcluaion for the prcpsration

ImpacT

a categorical
aaws.wwnr

0.r er,vironmentEl

statement

under

21 C.F.B.

9 25*30(a).

Even labeling on the container of certain food praAucts such aa dictnry supplements are allowed by law, and the FDA, to contain unapproved health claims SO long as they are accompanied by disclaimem such as, "These statements have not been evaluated by tia FDA. This product is not intended to diagnose, treat, cure, or prever,t any disease." If the governmental interest in protecting consumers can be caticfiorl by thic dicclaimcr on the yrducL ldkl iLsel.C, iL c:erk;:nhly c:ax hr: sntj.s.T:i&i by haviTlg simila,r djaclaimern placed on remote Internet l'labclinq.~
15

FlPR 16

01

02:54PM

011SENT

BY WFlSHINGTON

LEGAL

FNDN

P .27,32

E.

?!aohomi~

Impact

Btatcunwlt

Pet:itiolleL.
Commissioner
failure 1 C

will it
isUa

RMrnir
Ia
fcrmal

this
shl

intormation
L, @-.ition&r

upon request believes that

of

I ile

required.
a

FDR'a

pCiiCy

Classifyilly rsgardiqg as
advw-Ci

iTIfC1TmRCioIIa~

materialc dkwx:i ated

posted with
w0dii

on the variouc 1~3~

Jl'l;.rrnet products

the
n

health ilLcJ,

benefits than
iti

rather Thi s rather

label

kg,

a detrimental IllaLecials the eftcct

economic

effect.

becauee advcrtisiny, inkormation nrld other

regulcctinq would they

Internet have

;1~ labeling, of depriving

than of

CuIIsLlrnerR

would

oth~:7.wi~~ offer

LIB@to seek out health bexf;t..r

Convcrocly,

and consume food and enable the

tl-I .i si

products
Lu ledrl

that
healthier

ConSumerS petition

Lives,

granting

woulci

result

in

tbe

1710xe rITwt.i-tre

use

of

information

F _ Cereificatipn

The undercigncd and belitir, which

rqresm7tat

certify

that, include0

to LIM best all information includes

of their

knowledge 011

Lhis

petition

and virwti all

tbc

petition,
iVve

relies,
and

an11 I...t~al it kniormation

data

known to the pet..it.'it*jr~rz. which WLF reserves the right

of

arc

unfavorable

to the yei-.i t.ion. informatiori

to
its

sI.rXxrlit supplement petition.

and argument

in

~uppc~r~

FIPR 16

01

02:54PM

011SENT

BY WFlSHfNGTON

LEGFlL FNDN

P . ZBcl2

21

For the foregoing requests

that
IA~i~

reasons,

the Waehinqton

Lcqal

Foundation

yeLi.Lion

1x2 yrnnt.ed3.

Respectfully

submitted.

Gcnior

Executive

Counsel

WASHINGTON LEG?& FOUNDATION* Z!oUY MassachusettG Ave., N.W, Washington, D.C. 2003fi (ZU2) kJ,tik!-u302

cc:

Acting b'DA Commissioner Bernard Secretaq Tommy Tlx-1qwr11

Schwetz

WLb'

J&-kfer

wishes to express students Ellis,

its apgreciakion. to Sarah Key ar,d in WLF' s Economic: Freedom 11aW ~7 j S-I-~ d: r:

the Ccorqc Mclaon University in pw'paring this petltlon-

School oi: Law, for

their

assistance

P .29/32 QPR 16 ,;FIA O$:,Q)PM 011SENT BY WRSHINGTDN LEGaL FNDN

DEPARTMENT 0F HEALTH & HUMAN SERVICES

Food and Drug Adlllir~istration NQWEngland Disbict One MDntvalcAvenue Slaneham. Mas$iiuhusntrs02180 (T-81) 2f9.1675 FAX: (781) 27D-1742

WARNING LETTER NWE=OB-01 W

January 19,2Wl

Robert Hawlhorne, President Ocean Spray Crsrnberrieu, Inc. On0 Ocean Spray Drive Lakeville:Mi#dlcboro, Massachus&ts

02349

Ocar Mr. Hawthorne: fhe Food and Drug Administration (FDA) reviewed your firms intern& labeling fur your OWN-I Spray juice products, The container label for your gmpetruit juice pmduc;ls dire& the ww-wmer IO your wobsite via the staterrlwnt For grapefruit health facts visit: www,oceansplilyUrapefrult.com. The contoiner labels far your other Ocean spray juice producto: also bear youl irllrrrret webslte address wwW.oceanslrray.com. We have concluded that the labeling fourrd on your Internet sites causes your Ocenrr Spray Juice products to be in violatien of the !%dwral Fuod, Drug, and Cosmetic Ati [the At:t], and Title 21, Code of Federal Regulations [21 CFR]. Your Cran-l lealth, CISraptllruit Health, Press Releases and Juicti Nutrition 101 internct Eircs and related links cor.llHin unauthorized health claims. Unauthorized health claims thR products to be misbranded under sectiort dn.3(r)(l)(B) 111 labeling of foods cause the UTthe Act. The following are examples al some of rhe unauthorized health claims found on the w&site links listed above: Vitamin C in its 100% juice Ilne,,.associatcd with a reduced risk of chronic diseaccs b&h as cancer, cardiuvascular disease and cataracts, BeInca!oten%.,is 1 ~OWXIUI antioxidant...n.c;sociated with a reducmd risk of some c:ilrlcer.s. Bofh the Surgeon Generals Report all.4 lhe Natlonal Rcseerch Councils Rep~rl concluded rhot ccting plenty of foarls high In beta-carotcnc may protect against somt? epithcllal cancers, ., .citrus fruits may prolect against non homww dependent cancers, Flavonolds,L,teduco intravascular bloc,~l r-lr;lllirly...st~ke prevention, n, , ,cranberrieu may also prevent certain harmfrll bacteria irl Ihe mouth from Gticking to the teeth.. .bac\eria are ascociated with

QPR 16 01

02:54PM

011SEN-T BY WRSHINGTON LEGQL FNDN Page 2

..-_. _-. ^, P. 30/32

Rob& 1fawil~l~rr~r?, Presldenl Ocean Spray Cmnbcrries, Inc. Warning Letter NWEmO8-0.1 W

periodurilal gum dlseaoc, 1 Cranberry juice cocktail siyrtWit:antly inhlblred the E. coli bacteh, which cause 80 to uu psrccnt of UTls, from adhsring to 11~ urinary tract, preliminary resear& indicates thal rhc unique antioxidant compounds found in raspberties and grapes reduce th@ risk of oanccr and heafl disease. vitamin G..,helps prevent harnortllaying.. .and helps prevent viral infections such as the Common cold..,. and drinking CJIMglsss of grapefruit juice every day rntlwed rhe risk of srroke by 25%. your Grapefruit lkalth arid Cmn-Health website Jinh also contain other health daims the thar, aS wntlcn, do not contain ~11 elerrlents SGIforth in Title 21 code of Federal Reyulations [21 CFRI l+t? 101: Subpart E, for ttzir respective health claims. Thcrcfore, claims SKII as these listed betow arc also unauthoriztid healtl I claims, which cause the products to be misbratlded under secrion 408(r)(l)(B) of the Act; Folic acid.. .is important fur pregnant women because it helps prevent certain birth defects [21 CFR lOl.iR], .grapefrult pecrin (a soluble dicthry fiber) may protect againot hcclfi disease by lowering blood cholesterol [sl CFR 101,77J, %IcIuCIUpectin-rich foods IrKe Ocean Spray fresh ppfruit as pan of a lowfat,... plwverttionof heart disease121 CFR 101.77J, ...Amr~-ican Hearl Acoociation...stamp of approval 10 all Oman Spray Grapefruit juices and CI:enri SPmY fresh gtapsfruit...AHA~ heart check food cerrltication mixk informs COnSumerS theEc products are low in fat arld r:holestgrol which reduces the risk of heart dioease [?I GFH 101.751, and Crankeny Juice Cockall Pl I IS.. xontribures IO improved bone health, redllces the risk ul osieoporosis.. ,I pi CFR 101,72], l&r ithwtct kites alsa cantain clairrls indicating that the products are intended to treat, cure or mlllgara disease. Such claims are beyond rhe scope of the typos of claims that al-@~wmitred cn foods (e.g. structure!functinn claimr VI authorized heaitb claims) and are evitletr:ce that the products arc Intended fcr use as rlrr~~s within the meanlng of section Lol(g) of tl.)ti Act. The following are cxnmples of such claims found OII your websites: In cancer prone mice, resveratml appeared LCJ inhibit lesion development and rwhcc? skin tumor occurrence,. ,may help the hndy fight cancer., -combating initial celk&r 8nd sub-cellular damage to halting or slowing tumor ylpwth, Research shows grapwfrrri: juice slows breasr wncer growth.. . , In addition, incirkrlr:e of the spread of tumors to II tn Iwgs and lymph nodes was morksdly reduced in the cranbervfed group, I. ..may help lower cl &.s!erol in people wirh high blood cl70luslorol levels,, .,I (.,.cranbertys impottdnce as 4 promising rherapeuric tool 10 help fight bar.:kri~ narurally, ,..cranbcrys anti-stick effect t-nay fighl l-l. yyluri, the bacteria that are A cacw of some stomach ulcers..., FIavcncids...possess anIl-lnllammatory, anti-allergic, atifllr~ anticarclncgehic acrivltles . , , and ,,,a3 ihe i.r;sue of antibiotic rtxistarlce becomes more of a problham, drinking Ocean

P:31/32

(?PR 16 01

02:55PM

011SENT BY WFISHINGTON LEGFlL FNDN Paw

7

FloL~url Hawthnme. Prssident

Ocean Spray Crmbcrries, Inc. Warning LetterNWE-ORal W Spray cranberry juice cocktail every day may be a valuable measure for maintaining urinary rract heahh, In addition, statemfints on your wabske under Grapefruit .Illir;e and Cancer Care, pose a seiiouci saiety threat as tht+y not only overstate any possible benefit associated with grapefnrix juice consumption but also understate TJW very real risks associated with

of cettan drugs and grapefrulr luice. Your we&x& slates that rhe absorption and effecls of some medications. This statcmcnt reflects the abilily of grapefruit juice to block 111s malabolism of some dnlgs and, thereby, increase the blnud levels of thdso drugs. The statement Implies lhat the enhanced absorption and increased blued WeIs. arc a benefit. However, rhis statement may puse a SWICWC for patients on csrtain medications. risk
cmr,on&rlt use

grapefruit

juic:n enhances

The consumer would need 10 fitid a subsequent ulxwmbercd footnote to receive a pcrrfial list of medicatir:)rls thar may be aftccied by grapefluil juice and ro receive a mild admcnitlon to consult with a physician or pharmacist before taking the listed drugs, This presematibn not only trivializes a Ycrrious risk, but also is likely to prolrrote concomitant use r)f arap@fruitjuice and affected merlicatiorrr. Moreover, the site prot?Mes grapefruit juice for the miliyation of diecases and conditior,ls for which drugs are commnnly prescribed that intar& with grapefruit juice and for &kIl warnings are appropri;lio. For sxamplc, the site claims thal grapefruit juice can lower clwlesterol in pwple with high blood cholcstbrol levels, bui such parlencs may bc taking cholesterol-lowering, drugs, s~h as slmvastatin, the labeling of which warne about the risk of grapefrull j&e int*raclion. rho claims mxle fqr these products, e$ a legal nialler, subject them to the requirernenls for new drugs [QZOI (II)] because TherC no evidence that these products are generelly is recognized OS oafe and effective for their intended uses. TtIc?refore, rhey may not be legally markercd in the United %3lns withour approved New &rJg AgpkaTlonE [$505]. These producfs are also misbranded because your Ocean Spray juiCe pmducrs labeling fails to boar adsquato directions for IJSM[~502(f)(l)] and is false or misIeadIng @W(a)], as it sug~~ts that the products are safe and effective for their intendeci uses when this hao not been wst&lished. TiG (titter is nor intended to be an all-hciuuive review of all labeling ancj producrs vour firm markels. It is your responsibility to ensure that all product3 ma&etad by your firm are ih compliatrcs with the 4ct and ifs implementin@ regulation& We requesr that you take prompl action to corred these vicMir-x1s. Failure 10 promptly acrlon being initigted by HE FDA wilhaut further notice. The Act providco tar the seizure of illegal products and for injcltlction ctg;rlnst the manufiilclurer and/or dietributor of illagcll products.
co,rtir:l violations may result in enforcenlvrtt

P .32/32 ~IPR 16 01 C32:55PM DllSENT BY WASHINGTON LEGFIL FNDN

Robert Hawthorne, Warning

Fresida11

P3gc 4

Ocean Spray CmnherriPs, Inc.

Letter NWE-08.OlW

PIeaSe notify this office in wrldng within tieen (15) working days of receipt of this letter as to the specific steps you leave taken to correct the stated wir.~l.ations. You should al30 ir~lude an explanation of each step belng taken to identify and make cnrrections to assure rhar similar violations will not recur. If correoWc action cannol be cxlmpleled within fifteen (15) working day$, state Ihe lcrason for the delay and the time within whirAl the corrections will be Implemented. Your reply shouid be sm IO the aflentian of Mr. E. Frank Gesing, Compliar lrx Off Icer, at the above letterhenri address.

Sincerely,

District Director New Enyland Dlstrlct Office

FlPR 16 01

02: 46PM 011SENT ,BY WFlsHSNGTON ,&+&

~FNIJN,

P. 1~32---

WASHINGTON LEGAL FCIUNDATTCIN

2tM9 .blASSACXU~kTTS GVENCE, N.N. WASUINGTON, h.C. 20036 (2021 588-0302

CONFIDENTIAL

FACSlhrlLE COYER SHEET

TO: FDA- Uoclcets Managemertt .Rmdt

Fax:

From:Paulrx Kixncnar

COMMENIS:

Plea%hd enclosed a copy of our CitizensPetition; the otiginal and three copicvhavebeensene mail. Call if any q~esths, by